|Publication number||US7207965 B2|
|Application number||US 10/869,166|
|Publication date||24 Apr 2007|
|Filing date||16 Jun 2004|
|Priority date||16 Jun 2003|
|Also published as||CA2529495A1, CA2529495C, EP1638508A2, EP1638508A4, EP1638508B1, US20040254521, WO2004110391A2, WO2004110391A3|
|Publication number||10869166, 869166, US 7207965 B2, US 7207965B2, US-B2-7207965, US7207965 B2, US7207965B2|
|Original Assignee||Solx, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (105), Non-Patent Citations (2), Referenced by (70), Classifications (5), Legal Events (8)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims the benefit of U.S. Provisional Application No. 60/478,895, filed Jun. 16, 2003. This application is herein incorporated in its entirety by reference.
The present invention pertains to surgical treatments for glaucoma and methods for reducing intraocular pressure (IOP), and more particularly relates to an implantable shunt device for allowing aqueous outflows from the eye's anterior chamber and associated methods thereof.
Glaucoma is a major public health problem, affecting about two percent of the U.S. population and the third most common cause of blindness in the U.S. There are several forms of glaucoma however each results in elevated intraocular pressure (IOP) in the eye, which can cause progressive damage to the optic nerve, and both central and peripheral visual field loss. If the IOP remains high for an extended period of time, total vision loss can occur. The elevated IOP is caused by an imbalance in fluid inflows and outflows in the eye, and the pressure reduces the blood supply to the optic nerve. The principal objective of medical treatment is the lowering of intraocular pressure.
The anterior chamber of the eye contains the aqueous humor, a clear fluid that is produced continuously by the ciliary body around the lens. The constant flow of aqueous humor though the eye's front chamber exits through two different routes. A limited outflow occurs through the uveoscleral route, wherein fluid migrates outwardly between muscle fibers of the ciliary body. The primary aqueous outflow pathway is through the trabecular meshwork (TM) and the Schlemm's canal.
The trabecular meshwork is a filtering structure that extends around the circumference of the eye at the “angle”—the junction between the iris, sclera and cornea. The trabecular meshwork consists of layers of collagen webs that filter the outflows. The meshwork has a monolayer of trabecular cells that produce enzymes for degrading extracellular material that may be captured by the filtering structure.
Aqueous humor that passes through the trabecular meshwork flows into Schlemm's canal, which is a passageway or series of septae that extend around the circumference of the eye adjacent to the meshwork. The aqueous fluid thereafter flows through a series of collecting channels that drain from Schlemm's canal and into the episcleral venous system. In a normal eye, aqueous production by the ciliary body is equal to aqueous outflows to provide an IOP that remains constant in the 15 to 21 mm Hg range. In a patient suffering from glaucoma, the resistance through the outflow system is typically greater than 21 mm Hg. In primary open angle glaucoma (POAG), the most common form of glaucoma, the principal resistance to fluid outflow is centered about the region of trabecular meshwork that is adjacent Schlemm's canal. It is believed that an abnormal trabecular cell metabolism results in compacted meshwork layers or a build up of extracellular materials within the meshwork that inhibits fluid flows.
Numerous therapies have been developed for treating glaucoma by decreasing intraocular pressure. Pharmacological therapies include topical ophthalmic drops and oral medications that reduce the production of aqueous by the ciliary body or increase aqueous outflows via the uveoscleral route. The treatments generally require applications at least daily and are relatively expensive. Furthermore, drugs may have occasional serious side effects, such as blurred vision, allergic reactions, headaches and potentially dangerous interactions with other drugs.
Surgical approaches for treating open-angle glaucoma consist of laser trabeculoplasty, trabeculectomy, and the implantation of aqueous shunts. Trabeculectomy is a widely practiced surgery wherein microsurgical techniques are used to dissect the trabecular meshwork to allow more rapid aqueous outflow through the meshwork. The benefits of the dissection procedures diminish over time due to the body's wound healing response and resulting fibrosis that repairs and closes the dissected opening in the meshwork. After the dissections are healed up, the intraocular pressure again increases. Thus these expensive procedures do not provide a long-lasting cure.
Implantable shunts and surgical methods are also known for providing a fluid path for aqueous humor to exit the anterior chamber of the eye to the sclera or a space beneath the conjunctiva. See e.g., U.S. Pat. No. 6,050,970 to Baerveldt.
Trabeculectomies and shunt surgeries and variations thereof have several disadvantages and moderate success rates. Such surgeries require significant surgical skills to create an incision through the full thickness of the sclera into the subconjunctival space. Further, the surgeries cause substantial trauma to the eye. The procedures are generally performed in an operating room and have a prolonged recovery time. Thus, the state of the art shunts and surgical techniques have yet to provide a cost-effective and long-lasting solution which has short recovery periods and low risk.
What are needed, therefore, are devices and techniques for successful, long-term reduction in intraocular pressure.
One embodiment of the present invention provides a system for reducing intraocular hypertension, the system comprising an implantable shunt. The implantable shunt comprises a planar member and at least one microchannel disposed within the planar member. There is an inflow port disposed proximate to a first end of the microchannel and an outflow port disposed proximate to a second end of the microchannel, wherein the inflow port is configured such that when the implantable shunt is implanted, the inflow port is located about approximately within the region of an angle of an anterior chamber.
Another embodiment of the present invention provides such a system wherein the outflow port is disposed in a plane, that plane being chosen from the group consisting of a suprachoroidal plane and a suprascleral plane.
A further embodiment of the present invention provides such a system wherein the planar member has a thickness less than 50 microns.
Still another embodiment of the present invention provides such a system wherein the thickness of the planar member is between 5 and 25 microns.
A still further embodiment of the present invention provides such a system further comprising at least one anchor.
Even another embodiment of the present invention provides such a system wherein the anchor is selected from the group consisting of barbs, hooks, and sutures.
An even further embodiment of the present invention provides such a system further comprising at least one reservoir communicating with the first end of the microchannel. Yet another embodiment of the present invention provides such a system further comprising at least one reservoir communicating with the second end of the microchannel.
A yet further embodiment of the present invention provides such a system wherein the at least one microchannel comprises fewer than 200 microchannels. An even further embodiment provides such a system wherein the at least one microchannel comprises between 10 and 100 microchannels.
Still even another embodiment of the present invention provides such a system further comprising at least one sacrificial microchannel closure. A still even further embodiment of the present invention provides such a system wherein the closure is photo-ablatable. Yet even another embodiment of the present invention provides such a system wherein the closure is doped with chromophores.
Still yet another embodiment of the present invention provides such a system wherein the system is comprised of at least one biocompatible material selected from the group of biocompatible material consisting of gold, platinum, titanium, nickel, molybdenum, biocompatible metals, biocompatible metal alloys, biocompatible ceramics, biocompatible polymers and combinations thereof.
One embodiment of the present invention provides a method for the reduction of intraocular pressure in an eye of a subject, the method comprising providing an implantable planar microchannel shunt, implanting the shunt in the eye, such that a first end of the shunt is disposed proximate to an angle of an anterior chamber of the eye, and permitting aqueous flows to migrate from the anterior chamber through at least one microchannel disposed within the shunt.
Another embodiment of the present invention provides such a method further comprising photo-ablating tissue disposed between the first end and the anterior channel. A further embodiment provides such a method wherein photo-ablating tissue disposed between the first end and the anterior channel comprises retracting tissue anterior to the first end of the shunt, and photo-ablating an intervening tissue layer with a laser, such as an excimer laser or a titanium sapphire laser.
Even another embodiment of the present invention provides such a method further comprising photo-ablating a sacrificial microchannel closure, thereby increasing flow of the aqueous flow through the shunt. An even further embodiment provides such a method wherein photo-ablating the sacrificial microchannel closure comprises using a goniolens.
The features and advantages described herein are not all-inclusive and, in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the drawings, specification, and claims. Moreover, it should be noted that the language used in the specification has been principally selected for readability and instructional purposes, and not to limit the scope of the inventive subject matter.
One embodiment of the present invention comprises a thin planar shunt device that can have various shapes and configurations as depicted in
In this particular embodiment the shunt device is shown having a substantially planar body 102. However, the various embodiments of the present invention encompass generally planar bodies including convex bodies, concave bodies, and bodies of variable thickness as well as substantially planar bodies. For example, the body 102 can employ a wedge shape such that the thickness of the first end section 106A differs from the thickness of the second end section 106B. This includes variations of thickness throughout the first end section 106A, the medial section 107 and the second end section 106B along the longitudinal axis 105 as well as from side to side.
The shunt 100A has a plurality of microchannels 110 (collectively) each extending from an inflow port 112A in the first end section 106A to an outflow port 112B in the second end section 106B. The shunt 100A of
In some embodiments there are one or more microchannels 110 that are coupled between the endwise edges 104A, 104B with or without intersecting the reservoirs 115A, 115B. The endwise edges 104A, 104B of the microchannels can be open to allow additional fluid flow or closed at the endwise edge 104A, 104B depending upon the application. It should also be understood that the microchannel thickness can be uniform or non-uniform to include aspects wherein the area of the microchannel at the inflow port 112A is different that the area of the microchannel at the outflow port 112B.
The inflow and outflow ports, 112A and 112B, of the microchannels 110 are disposed generally about the periphery of the open portions or reservoirs 115A and 115B. The open portions 115A and 115B, in some embodiments, are adapted to provide a sufficient spacing or area to help insure that tissue is not excessively compressed against the inflow and outflow ports 112A, 112B which might limit fluid flow through the microchannels 110. The placement, size and shape of the reservoirs 115A, 115B can be varied to establish a long-lasting and satisfactory flow of fluid.
As depicted in
One embodiment of the present invention has been designed with the further aspect related to the prevention of wounds and intended to aid in the healing process. As in intravascular stents, coatings and additives may be applied, such as those used to prevent restenosis resulting from scarring and wound healing. Such coatings are familiar to one skilled in the art of medical devices, and may be mineral or ceramic coatings, pharmaceutical coatings, radiological coatings, polymer coatings, metallic coatings and combinations thereof. According to one embodiment, the use of selected materials and of any coatings is intended to reduce or minimize the attachment of tissue to the shunt and allow for fluidic flow about the shunt.
The shape of the shunt, according to one embodiment, has also incorporated certain features, such as rounded edges as opposed to sharp edges, to aid in preventing tissue from attaching to the shunt. Sharp edges on implants allow fibroblasts to adhere to the shunt, facilitating the growth of scar tissue around the shunt and the healing of the wound, while smooth edges do not provide such favorable sites for adhesion. Scar tissue is detrimental as is restricts flow of aqueous fluid into, out of, through and around the shunt, both from its increased density over ordinary structures in the angle of the anterior chamber, and from its healing of the wound. Fibroblasts may clog inlet ports and outlet ports of the shunt. The open wound itself permits the unobstructed flow of aqueous fluid into the shunt. The surgeon's adjustment of flow rate is, in part, effected by the unobstructed flow. Complete closure of the wound would inhibit the flow of aqueous, resulting in higher intraocular pressure than originally anticipated. Furthermore scarring around the shunt would complicate removal of the shunt should infection, clogging, or other occurrences render it inoperable and require its removal.
In some embodiments, such as that illustrated in
Now referring to
The width W of the implant body 102 ranges, in various embodiments, between about 0.5 mm. and 5.0 mm, and according to one embodiment is from about 1.0 mm to 4.0 mm. The length L, in various embodiments, ranges between about 2.0 mm. and 10.0 mm, and, in some embodiments, is about approximately between 4.0 mm and 8.0 mm. The thickness of the shunt body ranges, in various embodiments and shapes, from about 2 microns to 50 microns, and, in some embodiments, is about approximately between 5 microns and 20 microns. The number of microchannels 110 in the shunt body typically can range from one to a hundred or more.
In one embodiment the shunt is intended for a target IOP in the range of 8–16 mmHg. This is a working range for the operation of the shunt and the shunt is designed accordingly. There are fluid dynamic principles that assist in determining the characteristics of the microchannels and the number of microchannels required for a given application utilizing variable such as the IOP pressure, flow rate and the properties of the liquid.
According to one embodiment, the shunt is designed to operate in the target IOP employing about 60% of the microchannels being open to the fluid flow and about 40% closed. This allows the doctor to open additional channels as described herein as necessary to optimally maintain the IOP in the target range, this permits modulation, or in situ adjustment of flow rates to achieve optimal intraocular pressure. As such, the implant is able to modulate the fluid flow once the shunt is inserted in the eye, not merely avoiding excessively low intraocular pressures.
The alternative shunt 100E of
Now turning to
Now referring to
As can be seen in
In one embodiment, as can be understood from
Now turning to
As can be understood from
The lower body portion 102 b shows open microchannels 315 that connect the reservoirs 115A, 115B, as well as closed microchannels 310. In one embodiment the closed channels 310 are located at the inflow reservoirs 115A and are selectively openable. It is also within the scope of the invention to have open microchannels 315 that are selectively closeable by introducing a blockage or otherwise deliberately restricting channels based upon the IOP. There are various schemes to open and close the microchannels as known in the art or otherwise described herein. In one embodiment the open and closed microchannels 310, 315 are about 50 microns wide with 50 micron spacing.
An additional aspect of the invention is the use of a manipulation hole 340 that aids in holding the shunt 100 g during the insertion or extraction process. The oversized hole 340 provides the ability to grasp the shunt 100 g with an insertion tool (not shown). While a manipulation hole 340 is shown, there are various other manipulation feature that may be used in conjunction with the insertion tool.
In further embodiment there are one or more front channels 330 that provide additional fluid flow at the endwise edges and in one embodiment the front channels 330 are 50 microns wide and spaced approximately 350 microns apart. There may also at least one side channel 335 that can be formed on any or all of the sides of the shunt 100G to further allow fluid flow. In one embodiment the side channels 335 are 50 microns wide with 50 micron spacing on the inflow end and 50 microns wide with 150 micron spacing on the outflow reservoir. It should be understood that the number and size of the front and side channels is dependent upon the desired application.
As the shunt 100 g is intended as a less costly mechanism for glaucoma treatment, the present invention has been designed with ease of manufacturing as an additional feature. The size of the holes and channels take into account the capabilities of the manufacturing processes currently available. Improved manufacturing capabilities may alter certain attributes of the shunt and the present description is not to be limited accordingly.
The foregoing description of the embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of this disclosure. It is intended that the scope of the invention be limited not by this detailed description, but rather by the claims appended hereto.
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|International Classification||A61M5/00, A61F9/007|
|2 Jul 2004||AS||Assignment|
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